MAUDE Adverse Event Report: MEDCOMP REPAIR KIT

Model Number	RPK-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.When the investigation is complete a final report will be submitted.
Event or Problem Description
Blood leakage at the connection between the luer and the blood tubing set.This can be counteracted by a tightening of the connection.There have been no disconnections.
Additional Manufacturer Narrative
Root cause determined by the contract manufacturer and medcomp engineering: an evaluation of affected samples indicated an imperfect thread form, not passing iso-594-2 standard.The identified the root cause was the thread insert was not being properly ground.Corrective/preventative actions: the drawing for the luer was revised to depict correct luer thread, to add thread details and dimensions, and to add inspection keys to identify critical dimensions.Inspection of the threading insert next to the drawing.A 100% inspection of the luer taper and luer thread at the machine was instituted.A 100% inspection for final inspection of both luer characteristics prior to shipment.Implementation of the iso 80369-7 thread gage(s).

• Brand Name: REPAIR KIT
• Common Device Name: REPAIR KIT
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 7236872
• Report Number: 2518902-2018-00003
• Device Sequence Number: 1405501
• Product Code: NFK
• UDI-Device Identifier: 00884908039856
• UDI-Public: 884908039856
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Expiration Date: 08/01/2022
• Device Model Number: RPK-01
• Device Catalogue Number: RPK-01
• Device Lot Number: MCFH990
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2018
• Supplement Date Received by Manufacturer: 01/04/2018
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 07/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NIKKISO BLOOD LINES
• Outcome Attributed to Adverse Event: Required Intervention